MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Catalog Number 7510600

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Neuropathy (1983); Pain (1994); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Although it is unknown if the device contributed to the reported event, we are filing this mdr for notification purposes.

Event Description

It was reported that on: (b)(6) 2014: the patient was pre-operatively diagnosed with pseudoarthrosis l5-s1.Status post t10 to pelvis posterior spinal fusion in 2011 at an outside hospital.Adjacent segment kyphosis, adjacent segment disease with revision extension of fusion from t4 to t10.Prominent spinous processes high thoracic region.Osteoporosis.Delayed fusion, t10 to t11 and underwent the following procedures: removal of hardware t4 to the pelvis.Revision posterior spinal fusion t4 to the pelvis with local autograft and bone morphogenic protein.K2m mesa pedicle screw fixation t2 to the pelvis/revision posterior spinal fusion.As per op-notes, ¿bovie electrocautery was used for exposure down to the fusion mass and exposing the previous hardware.Depuy expedium and distal implants were removed using the hardware removal set.There was clear loosening at the s1 and iliac screw sites.Cobalt chrome rods were contoured to the appropriate sagittal profile and were inserted over the reduction devices to the appropriate fusion levels.It offset connectors -at the pelvis screw interface.There is clear fusion from t11 down to l5.Bony fusion bed was decorticated using a 4 ml steel bur and contouring of the prominent spinous process in the mid to high thoracic region was performed and this was used for additional autograft.Partial locking and final tightening of the k2 mesa implants were taken in lateral plane radiographs.Scoliosis film confirmed acceptable placement of all the implants.Bony surfaces areas were decorticated using a 4 mm steel bur.Bone morphogenic protein was placed at the thoracolumbar junction at the lumbosacral junction.The surgeon performed spine fusion surgery on the thoracolumbar region of the patients spine from vertebrae t4 to s1.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.The rhbmp-2 collagen sponge was placed outside a cage (i.E., in the disc space and at the thoracolumbar and lumbosacral junctions) the patient was transferred to recovery room in stable condition.Post-op, patient reported "progressively worsening mid and low back pain, and associated radiculopathy".Patient "continued to experience chronic mid and low back pain, with radiating pain into her hips and legs.Patient experiences difficulty sitting, standing and walking and requires a service dog for assistance".

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6889463
• MDR Text Key: 87199489
• Report Number: 1030489-2017-02094
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00681490843812
• UDI-Public: 00681490843812
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2015
• Device Catalogue Number: 7510600
• Device Lot Number: M111206AAV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/18/2017
• Initial Date FDA Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/05/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other